Regulatory Videos

  1. Advancing The Human Liver-Chip Toward FDA Qualification 9/30/2026

    Explore how human-relevant liver models can improve DILI risk assessment and support stronger development decisions while advancing toward regulatory qualification and scaling into automated studies.

  2. 2026 Regulatory Updates And Operation TrialBlazer 9/21/2026

    In this episode of “Better Biopharma,” host Tyler Menichiello is joined by former FDA staffers Eva Temkin, partner at Arnold & Porter, and Elizabeth Trentacost, senior associate at Arnold & Porter. They reflect on 2026 regulatory developments and discuss the implications and nuances of Operation TrialBlazer.

  3. Focusing On Quality Unit Independence With Tatyana Matveeva, Ph.D. 9/8/2026

    In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Tatyana Matveeva, Ph.D., an expert in cGMP manufacturing and regulatory compliance.

  4. Getting To A First Product Approval With Celcuity's Brian Sullivan 8/13/2026

    On this week's episode of the Business of Biotech, Brian Sullivan, CEO at Celcuity, talks about winning the company's first FDA approval for Revtorpyk, a kinase inhibitor for breast cancer patients, and why targeting an “untreated disease mechanism” can beat chasing a single mutation.

  5. Cell Therapy Without The Cells: Building A Therapeutic Secretome With Noveome Biotherapeutics' Larry Brown, Sc.D. 6/16/2026

    In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Larry Brown, Sc.D., chief scientific officer at Noveome Biotherapeutics, to discuss ST266, a first-of-its-kind secretome therapy.

  6. Cell & Gene: The Podcast Presents: Better Biopharma's Editors' Roundtable — A Midyear Look at the 2026 Life Sciences Industry 6/15/2026

    For episode 131 of Cell & Gene: The Podcast, we’re sharing a recent "Better Biopharma" roundtable that Erin Harris had the opportunity to join alongside her Life Science Connect editorial colleagues.

  7. The Editors' Roundtable: A Midyear Look At The 2026 Life Sciences Industry 6/5/2026

    On this week's episode of the Business of Biotech, Tyler Menichiello, chief editor at Bioprocess Online, host of the Better Biopharma podcast, and my Life Science Connect (LSC) colleague, convenes the broader LSC editorial team once again for a midyear discussion on what's happening now in the life sciences industry, and what's to come in the second half of the year.

  8. The Editors' Roundtable: A Midyear Look At The 2026 Life Sciences Industry 6/2/2026

    In this special edition of “Better Biopharma,” host Tyler Menichiello is joined by chief editors from across the Life Science Connect ecosystem to discuss what’s shaping the pharmaceutical industry in 2026. The editors reflect on recent developments in their respective spaces and make predictions on what the rest of the year has in store.

  9. Where Organ On Chips Will Add The Most Value In 3–5 Years 5/19/2026

    Panelists emphasized that CROs and CDMOs will be essential to scaling organ on chip adoption, but only if they commit to standardized, commercial execution rather than treating these systems as experimental add ons. As Don Ingber put it plainly, CROs “need to start buying these commercial systems and start scaling” them to make organ on chip studies operationally viable for industry.

  10. How FDA Policy And NCATS Are Supporting Organs On Chips 5/19/2026

    Christine Happle explains how FDA and NIH efforts are converging to move organ‑on‑chip and microphysiological systems from innovation toward regulatory credibility. She outlines how FDA has clarified expectations for new approach methodologies (NAMs) through structured qualification pathways, most notably the ISTAND program, which has now become a permanent mechanism for evaluating non‑animal methods within a defined context of use.